Ostomy pouch filter system

ABSTRACT

Ostomy appliances with a filter system that is resistant to clogging by waste expelled by the stoma are provided for waste management.

CROSS-REFERENCE

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 61/983,998, filed on Apr. 24, 2014, which is hereinincorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

An ostomy pouching system, or ostomy bag, is an ostomy appliance used tocollect waste from a stoma created from a surgically diverted biologicalsystem. Such ostomy bags are commonly associated with colostomies,ileostomies, and urostomies. Gas produced during digestion can inflateand compromise an air-tight ostomy bag. Gas management and odor removalhas been dealt with through the incorporation of a filter system withinthe ostomy bag, which vents this gas. It is desirable to design a filtersystem that is resistant to clogging by the accumulated waste within thepouch, thereby improving wear time of the ostomy bag.

SUMMARY OF THE INVENTION

In one aspect, disclosed herein are ostomy appliances comprising a frontpanel and a rear panel, at least partly sealed to one another alongtheir peripheries, said front and rear panels forming a pouch, the rearpanel having a stomal opening for positioning around a stoma so thatbody waste excreted through the stoma is captured in said pouch; afilter for deodorization of odorous gas from the body waste, said filterlocated on the front panel and said filter comprising an opening foremitting said deodorized gas to the atmosphere; and a center panelbetween the front and rear panels which at least partly covers saidfilter, the center panel having a bottom edge that is positioned abovethe bottom edges of the front and rear panels and is attached to thefront and rear panels along the periphery of the pouch; wherein at leastone of the center panel and front panel comprises one or moreprotrusions. In some embodiments, the center panel and front panel arepartly attached to one another. In further embodiments, the center paneland front panel are attached by a single weld located on the center ofthe bottom edge of the center panel. In still further embodiments, thecenter panel and the front panel have a protrusion-free portionpositioned between the filter and the single weld.

In some embodiments, the center panel comprises one or more protrusionsthat project toward the front panel. In some embodiments, the centerpanel comprises one or more protrusions that project toward the frontpanel and the front panel comprises one or more protrusions that projecttoward the center panel. In some embodiments, the front panel comprisesone or more protrusions that project toward the center panel.

In another aspect, disclosed herein are ostomy appliances comprising afront panel and a rear panel, at least partly sealed to one anotheralong their peripheries, said front and rear panels forming a pouch, therear panel having a stomal opening for positioning around a stoma sothat body waste excreted through the stoma is captured in said pouch; afilter for deodorization of odorous gas from the body waste, said filterlocated on the front panel and said filter comprising an opening foremitting said deodorized gas to the atmosphere; and a center panelbetween the front and rear panels which at least partly covers saidfilter, the center panel having a bottom edge that is positioned abovethe bottom edges of the front and rear panels and is attached to thefront and rear panels along the periphery of the pouch, the center paneland front panel being attached by a single weld located on the center ofthe bottom edge of the center panel; wherein the center panel comprisesone or more protrusions that project towards the front panel.

In another aspect, disclosed herein are ostomy appliances comprising afront panel and a rear panel, at least partly sealed to one anotheralong their peripheries, said front and rear panels forming a pouch, therear panel having a stomal opening for positioning around a stoma sothat body waste excreted through the stoma is captured in said pouch; afilter for deodorization of odorous gas from the body waste, said filterlocated on the front panel and said filter comprising an opening foremitting said deodorized gas to the atmosphere; and a center panelbetween the front and rear panels which at least partly covers saidfilter, the center panel having a bottom edge that is positioned abovethe bottom edges of the front and rear panels and is attached to thefront and rear panels along the periphery of the pouch, the center paneland front panel being attached by a single weld located on the center ofthe bottom edge of the center panel; wherein the center panel comprisesone or more protrusions that project towards the front panel, and thecenter panel and the front panel have a substantially protrusion-freeportion positioned between the filter and the single weld.

In some embodiments, the center panel comprises one or more protrusionswhich cover at least 50% of the surface area of the center panel. Insome embodiments, the center panel comprises one or more protrusionswhich cover at least 66% of the surface area of the center panel. Insome embodiments, the center panel comprises one or more protrusionswhich cover the entire surface area of the center panel.

In some embodiments, the one or more protrusions are half-spherical inshape. In some embodiments, the one or more protrusions are half-ovoidalin shape. In some embodiments, the one or more protrusions arepolyhedral in shape. In further embodiments, the one or more protrusionsare tetrahedral, pentahedral, or hexahedral in shape. In still furtherembodiments, the one or more protrusions have a top-face that istriangular, diamond-shaped, square-shaped, rectangular, pentagonal,hexagonal, heptagonal, or octagonal. In some embodiments, the one ormore protrusions form a labyrinth pattern. In some embodiments, each ofthe one or more protrusions is one of at least two different shapes. Insome embodiments, each of the one or more protrusions is one of at leasttwo different sizes. In some embodiments, the one or more protrusionsare arranged in columns. In some embodiments, the one or moreprotrusions are arranged in rows.

In some embodiments, the one or more protrusions are made of the samematerial as the center panel. In some embodiments, the one or moreprotrusions are integrally formed with the center panel.

In some embodiments, the filter is a round filter or a strip filter. Insome embodiments, the filter is a radial flow filter or an axial flowfilter.

In some embodiments, the pouch is drainable. In some embodiments, thepouch is closed.

In some embodiments, the center panel and front panel are attached byone or more additional welds located on the bottom edge of the centerpanel.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a rear elevational view of a first embodiment of an ostomyappliance in accordance with the present invention.

FIG. 2 is a front elevational view of the ostomy appliance of FIG. 1,without the stomal flange, for clarity.

FIG. 3 is a front elevational view of a first alternative embodiment ofFIG. 2, without the stomal flange, for clarity. This first alternativeembodiment features two additional short welds, each of which is locatedbetween a centrally located long weld and the periphery of the ostomyappliance.

FIG. 4 is a cross-sectional view along line A-A of a second alternativeembodiment of the ostomy appliance of FIG. 1. This second alternativeembodiment features fewer and larger-sized half-spherical protrusionsthan those shown in the ostomy appliance of FIG. 1. The protrusions inthis second alternative embodiment are not collapsed and fully projecttowards the front panel.

FIG. 5 is a cross-sectional view along line C-C of a second alternativeembodiment of the ostomy appliance of FIG. 1. This second alternativeembodiment is also shown in FIG. 3.

FIG. 6 is a front elevational view of a second embodiment of an ostomyappliance in accordance with the present invention.

FIG. 7 is a front elevational view of a third embodiment of an ostomyappliance in accordance with the present invention.

FIG. 8 is a front elevational view of a fourth embodiment of an ostomyappliance in accordance with the present invention.

FIG. 9 is a front elevational view of a fifth embodiment of an ostomyappliance in accordance with the present invention.

FIG. 10 is a front elevational view of a sixth embodiment of an ostomyappliance in accordance with the present invention.

FIG. 11 is a graph of the filter life of various tested ostomyappliances as defined by time to clog and as tested by tilt table.

DETAILED DESCRIPTION OF THE INVENTION

Ostomy pouch filters perform for a short time, usually a few hours andup to two days. These filters can fail by clogging which leads toballooning, insufficient deodorization, or leakage, and results inoverall reduced wear time of the pouch itself. The clogging may occurbecause the filter system becomes plugged or fouled with stool. As aresult, the pouch no longer vents properly, causing ballooning of thepouch or continued flow of escaping gas without deodorization of odor.Additionally, there can be leakage of stool outside of the pouch fromthe filter vent opening.

Provided herein are ostomy pouch filter systems to be used in an ostomyappliance. The ostomy pouch filter systems described herein provide amethod to resist clogging of the filter by waste within the ostomypouch. The structure of the ostomy pouch filter systems described hereinprovide a tortuous path for waste that may enter the system, whileallowing gas to pass freely to the filter.

Ostomy Appliance with Filter System

Disclosed herein, in certain embodiments, are ostomy appliances for themanagement of fecal or urinary waste. In some embodiments, the ostomyappliance comprises a front panel and a rear panel, at least partlysealed to one another along their peripheries, said front and rearpanels forming a pouch, the rear panel having a stomal opening forpositioning around a stoma so that body waste excreted through the stomais captured in said pouch; a filter for deodorization of odorous gasfrom the body waste, said filter located on the front panel and saidfilter comprising an opening for emitting said deodorized gas to theatmosphere; and a center panel between the front and rear panels whichat least partly covers said filter, the center panel having a bottomedge that is positioned above the bottom edges of the front and rearpanels and is attached to the front and rear panels along the peripheryof the pouch; wherein at least one of the center panel and front panelcomprises one or more protrusions. In further embodiments, the centerpanel and front panel are partly attached to one another. In stillfurther embodiments, the center panel and front panel are attached by asingle weld located on the center of the bottom edge of the centerpanel. In still further embodiments, the center panel and the frontpanel have a protrusion-free portion positioned between the filter andthe single weld. In still further embodiments, the center panel and thefront panel have a substantially protrusion-free portion positionedbetween the filter and the single weld.

In some embodiments, the ostomy appliance comprises a front panel and arear panel, at least partly sealed to one another along theirperipheries, said front and rear panels forming a pouch, the rear panelhaving a stomal opening for positioning around a stoma so that bodywaste excreted through the stoma is captured in said pouch; a filter fordeodorization of odorous gas from the body waste, said filter located onthe front panel and said filter comprising an opening for emitting saiddeodorized gas to the atmosphere; and a center panel between the frontand rear panels which at least partly covers said filter, the centerpanel having a bottom edge that is positioned above the bottom edges ofthe front and rear panels and is attached to the front and rear panelsalong the periphery of the pouch; wherein the center panel comprises oneor more protrusions that project toward the front panel. In furtherembodiments, the center panel and front panel are partly attached to oneanother. In still further embodiments, the center panel and front panelare attached by a single weld located on the center of the bottom edgeof the center panel. In still further embodiments, the center panel andthe front panel have a protrusion-free portion positioned between thefilter and the single weld. In still further embodiments, the centerpanel and the front panel have a substantially protrusion-free portionpositioned between the filter and the single weld.

In some embodiments, the ostomy appliance comprises a front panel and arear panel, at least partly sealed to one another along theirperipheries, said front and rear panels forming a pouch, the rear panelhaving a stomal opening for positioning around a stoma so that bodywaste excreted through the stoma is captured in said pouch; a filter fordeodorization of odorous gas from the body waste, said filter located onthe front panel and said filter comprising an opening for emitting saiddeodorized gas to the atmosphere; and a center panel between the frontand rear panels which at least partly covers said filter, the centerpanel having a bottom edge that is positioned above the bottom edges ofthe front and rear panels and is attached to the front and rear panelsalong the periphery of the pouch; wherein the front panel comprises oneor more protrusions that project toward the center panel. In furtherembodiments, the center panel and front panel are partly attached to oneanother. In still further embodiments, the center panel and front panelare attached by a single weld located on the center of the bottom edgeof the center panel. In still further embodiments, the center panel andthe front panel have a protrusion-free portion positioned between thefilter and the single weld. In still further embodiments, the centerpanel and the front panel have a substantially protrusion-free portionpositioned between the filter and the single weld.

In some embodiments, the ostomy appliance comprises a front panel and arear panel, at least partly sealed to one another along theirperipheries, said front and rear panels forming a pouch, the rear panelhaving a stomal opening for positioning around a stoma so that bodywaste excreted through the stoma is captured in said pouch; a filter fordeodorization of odorous gas from the body waste, said filter located onthe front panel and said filter comprising an opening for emitting saiddeodorized gas to the atmosphere; and a center panel between the frontand rear panels which at least partly covers said filter, the centerpanel having a bottom edge that is positioned above the bottom edges ofthe front and rear panels and is attached to the front and rear panelsalong the periphery of the pouch; wherein the center panel comprises oneor more protrusions that project toward the front panel and the frontpanel comprises at least one protrusion that projects toward the centerpanel. In further embodiments, the center panel and front panel arepartly attached to one another. In still further embodiments, the centerpanel and front panel are attached by a single weld located on thecenter of the bottom edge of the center panel. In still furtherembodiments, the center panel and the front panel have a protrusion-freeportion positioned between the filter and the single weld. In stillfurther embodiments, the center panel and the front panel have asubstantially protrusion-free portion positioned between the filter andthe single weld.

In some embodiments, the center panel comprises multiple protrusionswhich cover 20-50% of the surface area of the center panel. In someembodiments, the center panel comprises multiple protrusions which cover30-60% of the surface area of the center panel. In some embodiments, thecenter panel comprises multiple protrusions which cover 40-70% of thesurface area of the center panel. In some embodiments, the center panelcomprises multiple protrusions which cover 50-80% of the surface area ofthe center panel. In some embodiments, the center panel comprisesmultiple protrusions which cover 75-90% of the surface area of thecenter panel. In some embodiments, the center panel comprises multipleprotrusions which cover at least 50% of the surface area of the centerpanel. In some embodiments, the center panel comprises multipleprotrusions which cover at least 66% of the surface area of the centerpanel. In some embodiments, the center panel comprises multipleprotrusions which cover at least 80% of the surface area of the centerpanel. In some embodiments, the center panel comprises multipleprotrusions which cover the entire surface area of the center panel.

In some embodiments, the front panel comprises multiple protrusionswhich cover 20-50% of the surface area of the front panel. In someembodiments, the front panel comprises multiple protrusions which cover30-60% of the surface area of the front panel. In some embodiments, thefront panel comprises multiple protrusions which cover 40-70% of thesurface area of the front panel. In some embodiments, the front panelcomprises multiple protrusions which cover 50-80% of the surface area ofthe front panel. In some embodiments, the front panel comprises multipleprotrusions which cover 75-90% of the surface area of the front panel.In some embodiments, the front panel comprises multiple protrusionswhich cover at least 50% of the surface area of the front panel. In someembodiments, the front panel comprises multiple protrusions which coverat least 66% of the surface area of the front panel. In someembodiments, the front panel comprises multiple protrusions which coverat least 80% of the surface area of the front panel. In someembodiments, the front panel comprises multiple protrusions which coverthe entire surface area of the front panel.

In some embodiments, each of the center panel and the front panelcomprises multiple protrusions which cover 20-50% of the surface area ofeach of the center panel and the front panel. In some embodiments, eachof the center panel and the front panel comprises multiple protrusionswhich cover 30-60% of the surface area of each of the center panel andthe front panel. In some embodiments, each of the center panel and thefront panel comprises multiple protrusions which cover 40-70% of thesurface area of each of the center panel and the front panel. In someembodiments, each of the center panel and the front panel comprisesmultiple protrusions which cover 50-80% of the surface area of each ofthe center panel and the front panel. In some embodiments, each of thecenter panel and the front panel comprises multiple protrusions whichcover 75-90% of the surface area of each of the center panel and thefront panel. In some embodiments, each of the center panel and the frontpanel comprises multiple protrusions which cover at least 50% of thesurface area of each of the center panel and the front panel. In someembodiments, each of the center panel and the front panel comprisesmultiple protrusions which cover at least 66% of the surface area ofeach of the center panel and the front panel. In some embodiments, eachof the center panel and the front panel comprises multiple protrusionswhich cover at least 80% of the surface area of each of the center paneland the front panel. In some embodiments, each of the center panel andthe front panel comprises multiple protrusions which cover the entiresurface area of each of the center panel and the front panel.

In some embodiments discussed above and below, the substantiallyprotrusion-free portion positioned between the filter and the singleweld has less than 20% of the portion covered with protrusions. In someembodiments discussed above and below, the substantially protrusion-freeportion positioned between the filter and the single weld has less than15% of the portion covered with protrusions. In some embodimentsdiscussed above and below, the substantially protrusion-free portionpositioned between the filter and the single weld has less than 10% ofthe portion covered with protrusions. In some embodiments discussedabove and below, the substantially protrusion-free portion positionedbetween the filter and the single weld has less than 5% of the portioncovered with protrusions.

In some embodiments, the one or more protrusions are half-spherical inshape, half-ovoidal in shape, or polyhedral in shape, or a combinationthereof in shape. In some embodiments, the one or more protrusions arehalf-spherical in shape. In some embodiments, the one or moreprotrusions are half-ovoidal in shape. In some embodiments, the one ormore protrusions are polyhedral in shape. In some embodiments, the oneor more protrusions are tetrahedral in shape. In some embodiments, theone or more protrusions are pentahedral in shape. In some embodiments,the one or more protrusions are hexahedral in shape. In someembodiments, the one or more protrusions have a polygonal top-faceprojected towards either the center panel or the front panel. In someembodiments, the one or more protrusions have a diamond-shaped top-face.In some embodiments, the one or more protrusions have a triangulartop-face. In some embodiments, the one or more protrusions have asquare-shaped top-face. In some embodiments, the one or more protrusionshave a rectangular top-face. In some embodiments, the one or moreprotrusions have a pentagonal top-face. In some embodiments, the one ormore protrusions have a hexagonal top-face. In some embodiments, the oneor more protrusions have a heptagonal top-face. In some embodiments, theone or more protrusions have a octagonal top-face. In some embodiments,the one or more protrusions have a mixture of at least two shapes. Insome embodiments, the one or more protrusions form a labyrinth pattern.In some embodiments, the one or more protrusions are a truncatedhalf-sphere, truncated half-ovoid, or truncated polyhedron along theborder of a protrusion-free portion of the center and front panels. Insome embodiments, the one or more protrusions are uniform in size. Inother embodiments, the one or more protrusions vary in size. In someembodiments, the one or more protrusions vary in size and in shape

In some embodiments, the one or more protrusions are made of the samematerial as the center panel. In some embodiments, the one or moreprotrusions may be made of the same material as the center panel andshaped for example, by thermoforming. In some embodiments, the centerpanel is made of thermoplastic film. The thermoplastic film may bemonolayer or coextruded type. In some embodiments, the one or moreprotrusions are integrally formed with the center panel. In someembodiments, the one or more protrusions are made of different materialas the center panel and joined to the remainder of the center panel forform a unitary item. In some embodiments, the material of theprotrusions has the same thickness as the material for the remainder ofthe center panel. In other embodiments, the material of the protrusionshas a greater thickness than the material for the remainder of thecenter panel. In yet other embodiments, the material for the remainderof the center panel has a greater thickness than the material of theprotrusions.

In some embodiments, the one or more protrusions are made of the samematerial as the front panel. In some embodiments, the one or moreprotrusions may be made of the same material as the front panel andshaped for example, by thermoforming. In some embodiments, the frontpanel is made of thermoplastic film. The thermoplastic film may bemonolayer or coextruded type. In some embodiments, the one or moreprotrusions are integrally formed with the front panel. In someembodiments, the one or more protrusions are made of different materialas the front panel and joined to the remainder of the front panel forform a unitary item. In some embodiments, the material of theprotrusions has the same thickness as the material for the remainder ofthe front panel. In other embodiments, the material of the protrusionshas a greater thickness than the material for the remainder of the frontpanel. In yet other embodiments, the material for the remainder of thefront panel has a greater thickness than the material of theprotrusions.

In some embodiments, at least 5% of the protrusions on the center panelare collapsed so as not to fully project towards the front panel. Insome embodiments, at least 10% of the protrusions on the center panelare collapsed so as not to fully project towards the front panel. Insome embodiments, at least 20% of the protrusions on the center panelare collapsed so as not to fully project towards the front panel. Insome embodiments, at least 30% of the protrusions on the center panelare collapsed so as not to fully project towards the front panel. Insome embodiments, at least 40% of the protrusions on the center panelare collapsed so as not to fully project towards the front panel. Insome embodiments, at least 50% of the protrusions on the center panelare collapsed so as not to fully project towards the front panel. Insome embodiments, at least 60% of the protrusions on the center panelare collapsed so as not to fully project towards the front panel. Insome embodiments, at least 70% of the protrusions on the center panelare collapsed so as not to fully project towards the front panel. Insome embodiments, at least 80% of the protrusions on the center panelare collapsed so as not to fully project towards the front panel. Insome embodiments, at least 90% of the protrusions on the center panelare collapsed so as not to fully project towards the front panel. Insome embodiments, less than 20% of the protrusions on the center panelare collapsed so as not to fully project towards the front panel. Insome embodiments, less than 10% of the protrusions on the center panelare collapsed so as not to fully project towards the front panel.

In some embodiments, at least 5% of the protrusions on the front panelare collapsed so as not to fully project towards the center panel. Insome embodiments, at least 10% of the protrusions on the front panel arecollapsed so as not to fully project towards the center panel. In someembodiments, at least 20% of the protrusions on the front panel arecollapsed so as not to fully project towards the center panel. In someembodiments, at least 30% of the protrusions on the front panel arecollapsed so as not to fully project towards the center panel. In someembodiments, at least 40% of the protrusions on the front panel arecollapsed so as not to fully project towards the center panel. In someembodiments, at least 50% of the protrusions on the front panel arecollapsed so as not to fully project towards the center panel. In someembodiments, at least 60% of the protrusions on the front panel arecollapsed so as not to fully project towards the center panel. In someembodiments, at least 70% of the protrusions on the front panel arecollapsed so as not to fully project towards the center panel. In someembodiments, at least 80% of the protrusions on the front panel arecollapsed so as not to fully project towards the center panel. In someembodiments, at least 90% of the protrusions on the front panel arecollapsed so as not to fully project towards the center panel. In someembodiments, less than 20% of the protrusions on the front panel arecollapsed so as not to fully project towards the center panel. In someembodiments, less than 10% of the protrusions on the front panel arecollapsed so as not to fully project towards the center panel

In some embodiments, the height of the protrusion is 0.5 mm to 5.0 mm.In some embodiments, the height of the protrusion is 1.0 mm to 5.0 mm.In some embodiments, the height of the protrusion is 0.5 mm to 4.0 mm.In some embodiments, the height of the protrusion is 2.0 mm to 4.0 mm.In some embodiments, the height of the protrusion is 0.5 mm to 3.5 mm.In some embodiments, the height of the protrusion is 1.0 mm to 3.5 mm.In some embodiments, the height of the protrusion is 1.5 mm to 3.5 mm.In some embodiments, the height of the protrusion is 0.5 mm to 3.0 mm.In some embodiments, the height of the protrusion is 1.0 mm to 3.0 mm.In some embodiments, the height of the protrusion is 1.6 mm to 3.0 mm.In some embodiments, the height of the protrusion is 1.7 mm to 3.0 mm.In some embodiments, the height of the protrusion is 1.8 mm to 3.0 mm.In some embodiments, the height of the protrusion is 1.9 mm to 3.0 mm.In some embodiments, the height of the protrusion is 2.0 mm to 3.0 mm.

In some embodiments, the average width of the protrusion is 0.5 mm to10.0 mm. In some embodiments, the average width of the protrusion is 0.5mm to 8.0 mm. In some embodiments, the average width of the protrusionis 0.5 mm to 5.0 mm. In some embodiments, the average width of theprotrusion is 0.5 mm to 4.0 mm. In some embodiments, the average widthof the protrusion is 0.5 mm to 3.0 mm. In some embodiments, the averagewidth of the protrusion is 1.0 mm to 10.0 mm. In some embodiments, theaverage width of the protrusion is 1.0 mm to 8.0 mm. In someembodiments, the average width of the protrusion is 1.0 mm to 5.0 mm. Insome embodiments, the average width of the protrusion is 1.0 mm to 4.0mm. In some embodiments, the average width of the protrusion is 1.0 mmto 3.0 mm. In some embodiments, the average width of the protrusion is2.0 mm to 10.0 mm. In some embodiments, the average width of theprotrusion is 2.0 mm to 9.0 mm. In some embodiments, the average widthof the protrusion is 2.0 mm to 8.0 mm. In some embodiments, the averagewidth of the protrusion is 3.0 mm to 9 mm. In some embodiments, theaverage width of the protrusion is 3.0 mm to 8 mm. In some embodiments,the average width of the protrusion is 4.0 mm to 10.0 mm. In someembodiments, the average width of the protrusion is 4.0 mm to 9.0 mm. Insome embodiments, the average width of the protrusion is 4.0 mm to 8.0mm. In some embodiments, the average width of the protrusion is 1.0 mm.In some embodiments, the average width of the protrusion is 2.0 mm. Insome embodiments, the average width of the protrusion is 3.0 mm. In someembodiments, the average width of the protrusion is 4.0 mm. In someembodiments, the average width of the protrusion is 5.0 mm. In someembodiments, the average width of the protrusion is 6.0 mm. In someembodiments, the average width of the protrusion is 7.0 mm. In someembodiments, the average width of the protrusion is 8.0 mm.

In some embodiments, the protrusions are arranged in columns. In furtherembodiments, adjacent columns are offset with respect to each other. Insome embodiments, the protrusions are arranged in rows. In furtherembodiments, adjacent rows are offset with respect to each other.

In various embodiments, the spacing between protrusions is 1.0, 2.0,3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 13.0, 14.0, 15.0,16.0, 17.0, 18.0, 19.0, 20.0 mm or more, including increments thereinand combinations thereof. In some embodiments, the spacing betweenprotrusions is 2.0 mm to 5.0 mm. In some embodiments, the spacingbetween protrusions is 2.0 mm to 10.0 mm. In some embodiments, thespacing between protrusions is 3.0 mm to 6.0 mm. In some embodiments,the spacing between protrusions is 3.0 mm to 10.0 mm. In someembodiments, the spacing between protrusions is 4.0 mm to 8.0 mm. Insome embodiments, the spacing between protrusions is 4.0 mm to 10.0 mm.In some embodiments, the spacing between protrusions is 5.0 mm to 10.0mm. In some embodiments, the spacing between the protrusions is 3.0 mmto 4.0 mm.

The center panel may shield the filter from direct exposure to wasteexpelled from the stoma. In some embodiments, the bottom edge of thecenter panel is located below the horizontal pouch centerline. In otherembodiments, the bottom edge of the center panel is located above thehorizontal pouch centerline. In yet other embodiments, the bottom edgeof the center panel is located along the horizontal pouch centerline. Infurther embodiments, the bottom edge of the center panel is below thestomal opening such that the center panel completely covers the stomalopening. In other embodiments, the center panel only partially coversthe stomal opening. In some embodiments, the bottom edge of the centerpanel is below the stomal opening such that the center panel completelycovers the stomal opening, the bottom edge of the center panel beinglocated above the horizontal pouch centerline.

In some embodiments, the center panel and front panel are attached by asingle weld located on the bottom edge of the center panel. In someembodiments, the single weld is shorter in length than the diameter ofthe stomal opening. In other embodiments, the single weld is longer inlength than the diameter of the stomal opening. In still otherembodiments, the single weld is the same length as the diameter of thestomal opening. In some embodiments, the single weld is shorter inlength than the filter length or the diameter of the filter. In otherembodiments, the single weld is longer in length than the filter lengthor the diameter of the filter. In still other embodiments, the singleweld is the same length as the filter length or the diameter of thefilter. In some embodiments, the single weld is longer than the filterlength, or the diameter of the filter, but shorter than the diameter ofthe stomal opening. In other embodiments, the single weld is shorter inlength than the filter length, or the diameter of the filter, and thediameter of the stomal opening. In yet other embodiments, the singleweld is longer than the filter length, or the diameter of the filter,and the diameter of the stomal opening.

In some embodiments, the vertical single weld centerline is locatedalong the vertical pouch centerline. In other embodiments, the verticalsingle weld centerline is offset from the vertical pouch centerline.

In some embodiments, the center panel and front panel are attached bytwo or more welds located on the bottom edge of the center panel. Insome embodiments, two or more welds are positioned within 30 mm of thevertical pouch centerline. In some embodiments, two or more welds arepositioned within 40 mm of the vertical pouch centerline. In someembodiments, two or more welds are positioned within 50 mm of thevertical pouch centerline. In some embodiments, a first weld iscentrally located on the bottom edge of the center panel and one or moreadditional welds are located on the bottom edge of the center panelbetween the first weld and the periphery of the pouch. In furtherembodiments, the one or more additional welds are shorter in length thanthe first weld. In some embodiments, the first weld is about 10-50 mm inlength and each of the one or more additional welds are about 2 to 10 mmin length. In some embodiments the first weld is 50 mm in length andeach of the one or more additional welds are about 2 to 6 mm in length.

In some embodiments, the filter is a round filter or a strip filter. Insome embodiments, the filter is a round filter. In some embodiments, thefilter is a strip filter. In some embodiments, the filter is a radialflow filter or an axial flow filter. In some embodiments, the filter isa radial flow filter. In some embodiments, the filter is an axial flowfilter.

In some embodiments, the filter is located above the stomal opening,with no overlap of the filter with the stomal opening. In otherembodiments, the filter is located above the stomal opening, withpartial overlap of the filter with the stomal opening. In still otherembodiments, the filter and the stomal opening are positioned such thatthere is complete overlap between the filter and the stomal opening.

In some embodiments, the vertical filter centerline is located along thevertical pouch centerline. In some embodiments, the vertical filtercenterline and the vertical stomal opening centerline are located alongthe vertical pouch centerline. In other embodiments, the vertical filtercenterline is offset with respect to the vertical pouch centerline. Insome embodiments, the vertical centerlines of the filter and the stomalopening are located along each other but are offset with respect to thevertical pouch centerline. In some embodiments, the vertical centerlinesof the filter, the stomal opening, and the single weld are located alongthe vertical pouch centerline.

In some embodiments, the center panel and the front panel have aprotrusion-free portion positioned between the filter and the singleweld, such that the protrusion-free portion of the center panel that isexposed through the stomal opening is devoid of protrusions. In someembodiments, the center panel and the front panel have a protrusion-freeportion positioned between the filter and the single weld, such thatless than 50% of the surface area of the portion that is exposed throughthe stomal opening is covered by protrusions. In some embodiments, thecenter panel and the front panel have a protrusion-free portionpositioned between the filter and the single weld, such that less than40% of the surface area of the portion that is exposed through thestomal opening is covered by protrusions. In some embodiments, thecenter panel and the front panel have a protrusion-free portionpositioned between the filter and the single weld, such that less than30% of the surface area of the portion that is exposed through thestomal opening is covered by protrusions. In some embodiments, thecenter panel and the front panel have a protrusion-free portionpositioned between the filter and the single weld, such that less than20% of the surface area of the portion that is exposed through thestomal opening is covered by protrusions. In some embodiments, thecenter panel and the front panel have a protrusion-free portionpositioned between the filter and the single weld, such that less than10% of the surface area of the portion that is exposed through thestomal opening is covered by protrusions. In some embodiments, thecenter panel and the front panel have a protrusion-free portionpositioned between the filter and the single weld, such that less than5% of the surface area of the portion that is exposed through the stomalopening is covered by protrusions.

In some embodiments, the pouch is drainable. In some embodiments, thepouch is closed.

Referring to FIGS. 1-2, an ostomy appliance 10 comprises a firstembodiment of an ostomy pouch filter system. The ostomy appliancecomprises a front panel 11, a rear panel 12, and a center panel 13.Front panel 11 and rear panel 12 are welded along their peripheries 14and 15 except along their respective bottom edges 17 and 18 to form anostomy pouch 16. The non-welded bottom edges 17 and 18 may include adrainage aperture 19 for drainage of the effluent collected in pouch. Analternative embodiment (not shown) has the front and rear panelscompletely welded along their peripheries, creating a closed pouch. Asshown in FIG. 2, center panel 13 is viewed through the front panel 11.Center panel 13 is also welded to the front panel 11 and rear panel 12along the respective peripheries 14, 15, and 20, except along the bottomedge 21 of the center panel. The bottom edge 21 of the center panel ispositioned above the horizontal pouch centerline B-B. The center panel13 and the front panel 11 are attached to one another by a single weld22 located at the center of the bottom edge 21 of the center panel 13.The length of the single weld is shorter than the length of the filter.In alternative embodiments, the single weld is longer than the length ofthe filter.

The rear panel 12 has a stomal opening 23 for positioning around astoma, the stomal opening 23 located above the horizontal pouchcenterline B-B. The front panel 11 has a filter 24 located above thehorizontal pouch centerline B-B, positioned higher than the stomalopening 23 but also partly overlapping the stomal opening 23. Thevertical centerlines of the filter, the stomal opening, and the singleweld are located along the vertical pouch centerline A-A.

The front, rear, and center panels 11, 12, and 13 may be made offlexible plastics film that is generally impermeable to liquid and gas.A suitable film includes, for example, a laminate of one or more layersof ethylene vinyl acetate (EVA), and one or more layers of a gas barriermaterial, such as poly(vinylidene chloride) (PVDC). At least one of thefront and rear panels may further include one or more comfort layerslining the outer surface to provide a soft, comfortable outer surface.The films may be opaque. The films may be clear, or somewhat clear, sothat the user may see through at least one of the front, center, andrear panels 11, 12, and 13.

The center panel 13 has multiple uniformly sized half-sphericalprotrusions 25 arranged in columns in which each adjacent column isoffset with respect to each other. Each protrusion 25 projects towardsthe protrusion-free front panel 11, except if the protrusion 25 iscollapsed. A collapsed protrusion is not able to fully project thetop-face toward the front panel 11. The percentage of collapsedprotrusions is adjusted by choice and thickness of material for theprotrusions and/or method of protrusion preparation. A protrusion-freeportion 26 on the center panel 13 is positioned between the single weld22 and the filter 24, such that this portion 26 is in close contact withthe front panel 11, minimizing effluent flow through this part of thefilter system. The protrusion-free portion 26 of the center panel 13that is exposed through the stomal opening 23 also presents a smoothsurface to the stoma, reducing the potential for stomal irritation whenin contact with the stoma.

Referring to FIG. 3, an ostomy appliance comprises a first alternativeembodiment of an ostomy appliance 10 wherein two additional welds 22 aare located along the bottom edge 21 of the center panel 13 in additionto a weld 22. Weld 22 is centrally located and longer in length thaneither weld 22 a. Each weld 22 a is centrally located between weld 22and periphery 14. In other embodiments (not shown), an ostomy appliancehas one or more welds 22 a anywhere along the bottom edge 21 of thecenter panel in addition to weld 22. In still other embodiments (notshown), the one or more welds 22 a are located anywhere along bottomedge 21 between weld 22 and periphery 14. In some embodiments (notshown), the one or more welds 22 a are shorter than weld 22. In someembodiments (not shown), the one or more welds 22 a are the same lengthas weld 22. In some embodiments (not shown), the one or more welds 22 aare longer than weld 22.

Referring to FIGS. 4-5, an ostomy appliance comprises a secondalternative embodiment of an ostomy appliance 10 wherein the uniformlyhalf-spherical protrusions 25 are larger in size. As shown in FIGS. 4-5,the protrusions 25 are not collapsed and fully project towards the frontpanel 11.

Referring to FIG. 6, an ostomy appliance comprises a second embodimentof an ostomy pouch filter system comprising multiple uniformly sizedprotrusions with a polyhedral shape located only on the center panel.The diamond-shaped top-face of each protrusion projects toward the frontpanel, except if the protrusion is collapsed. A collapsed protrusion isnot able to fully project the top-face toward the front panel. Theprotrusions are arranged in offset rows. At the border of theprotrusion-free portion of the center panel between the single weld andthe filter, the protrusions may have a truncated cubic shape.

Referring to FIG. 7, an ostomy appliance comprises a third embodiment ofan ostomy pouch filter system comprising multiple uniformly sizedprotrusions with a polyhedral shape located only on the center panel.The triangular top-face of each protrusion projects toward the frontpanel, except if the protrusion is collapsed. A collapsed protrusion isnot able to fully project the top-face toward the front panel. Theprotrusions are arranged in offset rows. At the border of theprotrusion-free portion of the center panel between the single weld andthe filter, the protrusions may have a truncated shape.

Referring to FIG. 8, an ostomy appliance comprises a fourth embodimentof an ostomy pouch filter system comprising multiple protrusions with apolyhedral shape of two different sizes located only on the centerpanel. The diamond-shaped top-face of each protrusion projects towardthe front panel, except if the protrusion is collapsed. A collapsedprotrusion is not able to fully project the top-face toward the frontpanel. The protrusions are arranged in offset rows, with alternatingrows of protrusions with large diamond-shaped top-faces and rows ofprotrusions with small diamond-shaped top-faces. At the border of theprotrusion-free portion of the center panel between the single weld andthe filter, the protrusions may have a truncated shape.

Referring to FIG. 9, an ostomy appliance comprises a fifth embodiment ofan ostomy pouch filter system comprising multiple protrusions locatedonly on the center panel that create a labyrinth pattern. The top-faceof each protrusion projects toward the front panel, except if theprotrusion is collapsed. A collapsed protrusion is not able to fullyproject the top-face toward the front panel. At the border of theprotrusion-free portion of the center panel between the single weld andthe filter, the protrusions may have a truncated shape.

Other embodiments (not shown) of the ostomy appliance shown in FIGS. 4-9have one or more additional welds 22 a. The one or more additional weldsare located along anywhere along bottom edge 21 between weld 22 andperiphery 14. In some embodiments, the one or more welds 22 a areshorter than weld 22. In some embodiments, the one or more welds 22 aare the same length as weld 22. In some embodiments, the one or morewelds 22 a are longer than weld 22.

Referring to FIG. 10, an ostomy appliance comprises a sixth embodimentof an ostomy pouch filter system comprising multiple uniformly sizedprotrusions with a half-spherical shape located only on the centerpanel. The top-face of each protrusion projects toward the front panel,except if the protrusion is collapsed. A collapsed protrusion is notable to fully project the top-face toward the front panel. Theprotrusions are arranged in offset columns. The protrusions are locatedon the entirely of the surface area of the center panel, with noprotrusion-free portion between the single weld and the filter. There isno weld attaching the front and center panels. In other embodiments (notshown) of the sixth embodiment, the ostomy appliance has a single weld22 attaching the front and center panels. In other embodiments (notshown) of the sixth embodiment, the ostomy appliance has a single weld22 attaching the front and center panels and one or more welds 22 alocated along anywhere along bottom edge 21 between weld 22 andperiphery 14. In some embodiments, the one or more welds 22 a areshorter than weld 22. In some embodiments, the one or more welds 22 aare the same length as weld 22. In some embodiments, the one or morewelds 22 a are longer than weld 22.

In order to mimic actual usage of ostomy pouches with filters and assesstheir resistance to clogging, tests were conducted on a specificallydesigned “tilting table” test rig. The test rig was designed to hold thetest pouches in a vertical position and tilt to a horizontal position attimed intervals. The test rig also incorporated a means to inject airinto the test pouches to simulate gas produced by the body. The testpouches were filled with a simulated stool referred to as Feclone, whichwas mixed to a desired viscosity to challenge the filtering system froma clogging perspective. During the tests, each test pouch wascontinuously cycled through the vertical and horizontal positions, andthe filtering system of each test pouch was exposed to the simulatedstool and simulated gas at timed intervals of 10 minutes at eachposition. During each cycle, the test pouches were injected with enoughair to fill each pouch. The test pouch normally deflated by releasingthe air through the filter system, unless the filter system failed.Testing was continued until all pouches had failed, as observed by pouchballooning. When ballooning occurs, the simulated stool has clogged thefilter, preventing the release of air through the filter. The criteriafor filter system failure were the inability of the test pouch todeflate resulting in a fully ballooned pouch for three consecutive tilttable cycles.

Numerous commercial filtering systems were evaluated. Test results ofvarious pouch designs, with different filtering systems, are summarizedin FIG. 11. Filter system A (“Test Product A”) is one embodiment of thepresent invention and is illustrated in FIG. 10. Filter system B (“TestProduct B”) is another embodiment of the present invention and isillustrated in FIGS. 1-2. The test results indicated that Filter systemA had a 33% longer filter life than a filter system with a pleatedcenter panel incorporated in a commercially available ostomy pouch(Convatec Esteem Plus). Filter system B had a 150% longer filter lifethan a filter system with a pleated center panel incorporated in acommercially available ostomy pouch (“Commercial Product D”; ConvatecEsteem Plus).

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. An ostomy appliance comprising a. a front paneland a rear panel, at least partly sealed to one another along theirperipheries, said front and rear panels forming a pouch, the rear panelhaving a stomal opening for positioning around a stoma so that bodywaste excreted through the stoma is captured in said pouch; b. a filterfor deodorization of odorous gas from the body waste, said filterlocated on the front panel and said filter comprising an opening foremitting said deodorized gas to the atmosphere; and c. a center panelbetween the front and rear panels which at least partly covers saidfilter, the center panel having a bottom edge that is positioned abovethe bottom edges of the front and rear panels and is attached to thefront and rear panels along the periphery of the pouch; wherein at leastone of the center panel and front panel comprises one or moreprotrusions.
 2. The ostomy appliance of claim 1, wherein the centerpanel and front panel are partly attached to one another.
 3. The ostomyappliance of claim 2, wherein the center panel and front panel areattached by a single weld located on the center of the bottom edge ofthe center panel.
 4. The ostomy appliance of claim 3, wherein the centerpanel and the front panel have a protrusion-free portion positionedbetween the filter and the single weld.
 5. The ostomy appliance of anyone of the preceding claims, wherein the center panel comprises one ormore protrusions that project toward the front panel.
 6. The ostomyappliance of any one of claims 1-4, wherein the center panel comprisesone or more protrusions that project toward the front panel and thefront panel comprises one or more protrusions that project toward thecenter panel.
 7. An ostomy appliance comprising a. a front panel and arear panel, at least partly sealed to one another along theirperipheries, said front and rear panels forming a pouch, the rear panelhaving a stomal opening for positioning around a stoma so that bodywaste excreted through the stoma is captured in said pouch; b. a filterfor deodorization of odorous gas from the body waste, said filterlocated on the front panel and said filter comprising an opening foremitting said deodorized gas to the atmosphere; and c. a center panelbetween the front and rear panels which at least partly covers saidfilter, the center panel having a bottom edge that is positioned abovethe bottom edges of the front and rear panels and is attached to thefront and rear panels along the periphery of the pouch, the center paneland front panel being attached by a single weld located on the center ofthe bottom edge of the center panel; wherein the center panel comprisesone or more protrusions that project towards the front panel.
 8. Anostomy appliance comprising a. a front panel and a rear panel, at leastpartly sealed to one another along their peripheries, said front andrear panels forming a pouch, the rear panel having a stomal opening forpositioning around a stoma so that body waste excreted through the stomais captured in said pouch; b. a filter for deodorization of odorous gasfrom the body waste, said filter located on the front panel and saidfilter comprising an opening for emitting said deodorized gas to theatmosphere; and c. a center panel between the front and rear panelswhich at least partly covers said filter, the center panel having abottom edge that is positioned above the bottom edges of the front andrear panels and is attached to the front and rear panels along theperiphery of the pouch, the center panel and front panel being attachedby a single weld located on the center of the bottom edge of the centerpanel; wherein the center panel comprises one or more protrusions thatproject towards the front panel, and the center panel and the frontpanel have a substantially protrusion-free portion positioned betweenthe filter and the single weld.
 9. The ostomy appliance of any one ofthe preceding claims, wherein the center panel comprises one or moreprotrusions which cover at least 50% of the surface area of the centerpanel.
 10. The ostomy appliance of any one of the preceding claims,wherein the center panel comprises one or more protrusions which coverat least 66% of the surface area of the center panel.
 11. The ostomyappliance of claim 5 or claim 7, wherein the center panel comprises oneor more protrusions which cover the entire surface area of the centerpanel.
 12. The ostomy appliance of any one of claims 1-4, wherein thefront panel comprises one or more protrusions that project toward thecenter panel.
 13. The ostomy appliance of any one of claims 1-12,wherein the one or more protrusions are half-spherical in shape.
 14. Theostomy appliance of any one of claims 1-12, wherein the one or moreprotrusions are half-ovoidal in shape.
 15. The ostomy appliance of anyone of claims 1-12, wherein the one or more protrusions are polyhedralin shape.
 16. The ostomy appliance of any one of claims 1-12, whereinthe one or more protrusions form a labyrinth pattern.
 17. The ostomyappliance of claim 15, wherein the one or more protrusions aretetrahedral, pentahedral, or hexahedral in shape.
 18. The ostomyappliance of claim 17, wherein the one or more protrusions have atop-face that is triangular, diamond-shaped, square-shaped, rectangular,pentagonal, hexagonal, heptagonal, or octagonal.
 19. The ostomyappliance of any one of claims 1-12, wherein each of the one or moreprotrusions is one of at least two different shapes.
 20. The ostomyappliance of any one of claims 1-12, wherein each of the one or moreprotrusions is one of at least two different sizes.
 21. The ostomyappliance of any one of the preceding claims, wherein the one or moreprotrusions are arranged in columns.
 22. The ostomy appliance of any oneof the preceding claims, wherein the one or more protrusions arearranged in rows.
 23. The ostomy appliance of any one of the precedingclaims, wherein the filter is a round filter or a strip filter.
 24. Theostomy appliance of any one of the preceding claims, wherein the filteris a radial flow filter or an axial flow filter.
 25. The ostomyappliance of any one of the preceding claims, wherein the one or moreprotrusions are made of the same material as the center panel.
 26. Theostomy appliance of any one of the preceding claims, wherein the one ormore protrusions are integrally formed with the center panel.
 27. Theostomy appliance of any one of claims 1-26, wherein the pouch isdrainable.
 28. The ostomy appliance of any one of claims 1-26, whereinthe pouch is closed.
 29. The ostomy appliance of any one of claims 1-28,wherein the center panel and front panel are attached by one or moreadditional welds located on the bottom edge of the center panel.